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The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7.5ug H1N1 vaccine | Experimental | 360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21. |
|
| 15ug H1N1 vaccine | Experimental | 360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21. |
|
| seasonal influenza vaccine | Placebo Comparator | 180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7.5ug H1N1 Influenza vaccine | Biological | 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21 |
|
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lingchuan County CDC | Recruiting | Guilin | Guangxi | 541000 | China |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| 15ug H1N1 vaccine | Biological | 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21 |
|
| seasonal influenza vaccine | Biological | 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21 |
|
| Luxi County CDC | Recruiting | Xiangxi Prefecture | Hunan | 416100 | China |
|
| Yandu District CDC | Recruiting | Yancheng | Jiangsu | 224001 | China |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |